Sr Safety Specialist (Night Shift)

Position Overview

• Location Type: [Not Specified]
• Job Type: Full-time
• Work Schedule: Standard (Mon-Fri)
• Environment: Office
• Salary: [Not Specified]

This role performs and may oversee day-to-day Pharmacovigilance (PV) activities within a highly regulated environment, driven by strict timelines. PV activities include collection, monitoring, assessment, evaluation, research, and tracking of safety information. The position requires optimal collaboration with project team members, client contacts, investigators, adverse event reporters, and third-party vendors.

Key Responsibilities

• Independently performs day-to-day PV activities.
• May participate in on-call duties for specific projects to ensure 24-hour coverage for intake of cases from investigative sites.
• Operates in a lead capacity.
• Provides assistance in the development of program and departmental procedural documents.
• May prepare for and attend audits.
• Mentors less expert staff.
• Reviews regulatory/pharmacovigilance publications and information sources to stay updated on current regulations, practices, procedures, and proposals.
• Maintains medical understanding of applicable therapeutic areas and disease states.
• Reviews cases for quality, consistency, and accuracy, including peer report reviews.
• Responsible for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee).
• Includes presentations at client/investigator meetings.
• Involves review of metrics and budget considerations.

Education and Experience

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Knowledge, Skills, and Abilities

• Thorough understanding of pathophysiology and the disease process.
• Solid understanding of relevant therapeutic areas as needed for processing Adverse Events (AEs).
• Excellent critical thinking and problem-solving skills with the ability to evaluate and escalate appropriately.
• Proficient in sophisticated clinical study administration, including budget activities and forecasting.
• Excellent oral and written communication skills, including paraphrasing skills.
• Good command of English and ability to translate information into local language where required.
• Computer literate with the ability to work within multiple databases.
• Proficient in Microsoft Office products (including Outlook, Word, and Excel).
• Thorough understanding of global regulatory requirements and the importance of and compliance with procedural documents and regulations.
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision.
• Strong attention to detail.
• Ability to maintain a positive and professional demeanor in exciting circumstances.
• Ability to work effectively within a team to attain a shared goal.